Cybin Completes Dosing In Phase 2 Study Of CYB003 For Major Depressive Disorder Treatment

Cybin Inc. CYBN, a clinical-stage biotech company developing novel psychedelic-based mental health treatments, has completed dosing of the final participant cohort in the Phase 2 study on its deuterated psilocybin analog CYB003 assessed for Major Depressive Disorder (MDD) treatment.

This clinical phase of the CYB003 program, which is backed by a composition of matter patent providing protection until 2041) is expected to provide topline efficacy data before the year ends. 

CEO Doug Drysdale says the team is thrilled with the “rapid progression” from dosing initiation to completion across all trial cohorts. Cybin will now focus on the upcoming data submission to the FDA toward a potential scaling to a Phase 3 pivotal study in early 2024, a “value inflection point” for the company.

Preparations for the Phase 3 trial include GMP production (on track) to begin dosing with a novel, stable and dose-flexible capsule formulation, developing a scalable version of the facilitators training program EMBARK and partnering with Worldwide Clinical Trials.

Trial Details

The Phase 1/2 study is evaluating CYB003’s safety, tolerability, PK/PD and psychedelic effect in ascending oral doses in both participants with moderate-to-severe MDD and healthy volunteers. 

The latter received two administrations (placebo/active and active/active) one week apart, with measures of psychedelic effect assessed after each dose. 

MDD participants received two administrations (placebo/active and active/active) three weeks apart, with response and remission assessed three weeks after each dose, plus evaluation of rapid onset of antidepressant effect on dosing day and incremental benefit of a second dose administered at week 3.

An optional period of assessment will help determine the durability of the treatment's effect out to 12 weeks. 

Throughout the six cohorts, the study evaluated CYB003 doses of 1mg, 3mg, 8mg, 10mg, 12mg and 16mg, all of which to date “have been shown to be safe and tolerable,” no serious adverse events or discontinuations due to adverse events observed in the final (and highest) dose cohort.

Photo: Benzinga edit with photo by Olia Danilevich on Pexels.